Colonoscopy Using Motorized Spiral Enteroscope

Colon Disease Clinical Trial

Official title:

Colonoscopy Using Motorized Spiral Enteroscope: Prospective Bi-center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04895254
• Other study ID #: W2021.204
• Status: Completed
• Start date: May 25, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2022
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The new technology of the motorized Spiral enteroscope, originally developed for deep small bowel enteroscopy, might potentially overcome some limitations of standard colonoscopy.

Description:

Cecal intubation rate represents a key procedural quality parameter in diagnostic colonoscopy. However, even in experienced hands, a significant percentage of colonoscopies (1.6-16.7%) remain incomplete because of a failure to intubate the cecum. The new technology of the motorized Spiral enteroscope, originally developed for deep small bowel enteroscopy, might potentially overcome some limitations of standard colonoscopy. The study aim was to evaluate the feasibility and safety of motorized Spiral enteroscopy for difficult colonoscopies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Indications for Spiral colonoscopy as a rescue procedure because of incomplete antecedent colonoscopy

Exclusion Criteria:

• Age under 18 years

• Known pregnancy

• Poor health status (ASA classification = 4)

• Contraindication for sedation or standard colonoscopy

• Known coagulopathy (INR = 2.0, platelets < 70 /nl) or anticoagulants other than aspirin

• Medical history of chronic inflammatory bowel disease or suspected bowel obstruction

Related Conditions & MeSH terms

• Colon Disease
• Colonic Diseases

Intervention

Device:
• Diagnostic colonoscopy
The feasibility of the motorized spiral enteroscope to achieve cecum intubation in difficult colons.

Procedure:
• Therapeutic colonoscopy
The feasibility of the motorized spiral enteroscope for performing interventions such as polypectomy

Locations

Country	Name	City	State
Netherlands	University Medical Centre Groningen	Groningen
Netherlands	St Antonius hospital	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate the feasibility of motorized PowerSpiral enteroscopy for difficult colonoscopies	achieving cecum intubation in difficult colons	during procedure
Primary	evaluate the safety of motorized PowerSpiral enteroscopy for difficult colonoscopies	Registering adverse events	7 days
Secondary	Endoscopic mucosal resection	Performing endoscopic mucosal resection on polyps	during procedure